EMKinetics, Inc. announced today initiation of the TranStim™ Transdermal Neuromodulation System pivotal trial for patients suffering from urge incontinence and overactive bladder. The 120-person trial will be conducted at 10-15 US centers. Submission for CE mark and 510(k) clearance will follow the completion of the study. EMKinetics' TranStim therapy builds on the body of evidence that posterior tibial nerve stimulation (PTNS) can generate a clinically significant improvement in patients suffering from urge incontinence and overactive bladder.
"This appears to be the next evolutionary step for PTNS technology," said Marshall Stoller, MD, EMKinetics co-founder and professor and vice chair in the Department of Urology at the University of California, San Francisco. "We are confident that the TranStim System has the potential to safely and consistently provide transdermal PTNS therapy. We believe this advancement will be well received by this desperate patient population and the physicians caring for them."
The initiation of the pivotal trial follows the closing of EMKinetics' Series C financing of $8.0 million, led by a strategic investment from Allergan, Inc., a global multi-specialty healthcare company with a strong and growing urology portfolio. Series B investor, Scientific Health Development, and four new institutional investors, Easton Capital, Oakwood Medical Investors, Legacy Life Sciences and Millennium Life Sciences Fund, filled out the round.
"Allergan, which is widely known for its specialty pharmaceuticals, has also become a significant participant in medical devices and is emerging as a leader in urologic therapies", said Daniel Burnett, MD, co-founder and director of EMKinetics. "Their financial support in an area they know so well is both gratifying and important to our company."